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Welcome to OncologyPRO, the home of ESMO’s educational and scientific resources, with Guidelines, a comprehensive list of E-Learning modules, Factsheets on biomarkers, slides and webcasts from our educational programme, and more... to support continuing medical education and daily practice!

Nivolumab demonstrated OS benefit in patients with advanced squamous cell NSCLC in a phase III CheckMate 017 study. Based on results of that study, the US FDA on 4 March 2015 approved nivolumab as a second-line treatment for advanced squamous cell NSCLC. On 21 May 2015, the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorisation for nivolumab, intended for the treatment of adults with locally-advanced or metastatic squamous cell NSCLC.

Patients were randomised to nivolumab (n=292) or docetaxel (n=290) until progression or discontinuation due to toxicity and other reasons. The primary objective of the study was OS. Secondary objectives were investigator-assessed ORR which was measured by RECIST v1.1 criteria, progression-free survival (PFS), efficacy by PD-L1 expression, quality of life, and safety.

PD-L1 expression was associated with benefit from nivolumab. In PD-L1-positive patients, nivolumab showed improved efficacy across all endpoints at predefined 1%, 5%, and 10% cut-off points. PD-L1 expression was predictive of benefit with nivolumab, starting at the lowest expression level (1%).

Median OS nearly doubled with nivolumab vs docetaxel across PD-L1 expression continuum. No difference in OS was seen when PD-L1 was not expressed in the tumour. The ORR nearly tripled in PD-L1 expressors. Median DoR was longer with nivolumab vs docetaxel in both PD-L1 expressors and non-expressors across all expression levels.

Grade 3–5 drug-related adverse events occurred in 10.5% of nivolumab and 53.7% of docetaxel patients. No deaths were related to nivolumab vs one docetaxel-related death. After discontinuation, 42.1% of nivolumab and 49.7% of docetaxel patients received subsequent systemic therapy.

“Is this truly Chakemate?”

Dr Roy Herbst who discussed the study results tried to answer if the results of this study are truly “checkmate”. He said that CheckMate 057 is a practice changing and set a new standard of care in patients with previously treated non-squamous cell NSCLC. It is a positive randomised phase III study that met primary endpoint. There is a particularly long benefit in a select population of patients, even in the absence of clearly defined response. He pointed to the delayed effects of immunotherapy.

Although the biomarker data showed significant outcomes for patients expressing any level of PD-L1, PD-L1 expression was determined using archival specimens and was not available for all patients. Despite the fact that these studies are hypothesis generating, Dr Herbst commented that more work is needed before PD-L1 expression is used to determine treatment in the second-line setting and that patients were not prospectively stratified. Dr Herbst noted that the field is now grappling with multiple biomarkers associated with different immunotherapy drugs.

Nivolumab is significantly less toxic than docetaxel. Dr Herbst further noted that although positivity for the PD-L1 biomarker does improve ORR, PFS, and OS with nivolumab, even the group with less than 1% expression appeared to have at least equal activity to that of docetaxel. However, PD-L1 biomarker should not yet be used for patient selection.

Future studies are warranted to benefit a greater number of patients, in particular Dr Herbst elaborated opportunities from testing in front line therapy, as adjuvant treatment in earlier stage disease, exploring activity in patients with ALK and EGFR mutations, small-cell lung cancer, and exploring biomarkers and science to develop new combinations.